MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ACT1530
Medical Device Problem Code	Ambient Temperature Problem (2878)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during rfa for liver cancer, ablation was attempted but the target lesion did not seem to be ablated; ablation was attempted for 12 minutes, but still no change was seen.The needle was replaced with new one, and ablation was successful.The procedure was completed.There was no patient harm.

• Brand Name: COOL-TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7542438
• Report Number: 1717344-2018-00755
• Device Sequence Number: 1529216
• Product Code: GEI
• UDI-Device Identifier: 10884524000947
• UDI-Public: 10884524000947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: ACT1530
• Device Catalogue Number: ACT1530
• Device Lot Number: 73130320X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1